LifeScience India October-November 2012 issue

LSI
SPOTLIGHT

the country’s largest drug maker, could sell its own version hefty cost of cancer drugs takes a toll on the patient. Cipla's
of the lung cancer drug, Tarceva (erlotinib) which is made Erlocip costs Rs 1,600 a tablet compared to Rs 4,800 a tablet
by Roche. The generic version will reportedly cost about a for Roche's Tarceva, making the drug affordable to thou-
third of the proprietary version. Another, landmark case sands of patients.
is currently being fought by Swiss pharma giant Novartis
in India’s Supreme Court. The company wants to patent This landmark judgement has also paved the way for other
and sell its anti-cancer drug, imatinib mesylate, known as generic companies. In fact, the ruling comes out as a big
Glivec, in India but, so far, its efforts have failed. These ver- boost for legal prospects of Indian generic-drug makers
dicts are important as they will clarify the implementation like Natco Pharma Ltd, Dr. Reddy's laboratories Ltd and
of the amended Indian Patents Acts – particularly on issues Glenmark Pharmaceuticals Ltd, which have also been sued
regarding the interpretation and assessment of efficacy of by Roche over the same drug. “This Delhi High Court or-
the medicine seeking a product patent. der will definitely have a positive impact on other pend-
ing cases provided the Indian companies are on stronger
CIPLA vs. Roche: Validity of patent grounds”, says Dr. Antani.

The four year long tussle between India’s biggest generics Cipla opposition to Pfizer’s cancer drug
giant Cipla and Swiss drug maker F. Hoffmann-La Roche
Ltd came to an end when very recently, the Delhi High The first week of October saw a similar milestone case
Court, on September 7th, ruled out the case of patent in- which delivered another blow to MNC drug majors, when
fringement filed by the Swiss company on Cipla. Roche had the Indian patent office revoked US-based Pfizer's patent
filed a case of patent infringement against Cipla in 2008. for cancer drug Sutent in India. The post-grant opposition
As per the Delhi High Court, Cipla's drug - Erlocip did not was filed by Cipla and Natco Pharma. India's Patent Board
violate the Roche patent on its anti-lung cancer medication has backed the latter firm, saying that "the invention that is
Tarceva due to its different molecular make-up. claimed in the patent does not involve any inventive step".
Pfizer, which was granted a patent for its kidney cancer drug
Justice Manmohan Singh observed in his 280-page judg- Sutent (sunitinib) in India in 2007, has priced the drug at Rs
ment that it had been scientifically proven that Cipla’s ge- 1.96 lakh for a 45-day treatment. A lot is bound to happen
neric version was a polymorph B variant of Roche’s pat- in the coming months. The Indian patenting system will
ented drug and that it didn’t actually infringe any patent draw several questions, big pharma companies may outcry
in India. “This is a landmark judgement; it has upheld the and shy away from bringing in their new inventions, while
patent of Roche, at the same time ruled that Cipla's ver- the Indian generic industry will have more scope to clone
sion is valid”, says Dr. Milind Antani of Nishith Desai new drugs.
Associates. Prity Khastgir, Managing Partner and Patent
& Trademark Attorney at Tech Corp Legal, a New Delhi The 3(d) effect
based LLP says, “This decision has not completely turned
the tables in favour of generics, but has given a strong mes- The long drawn law suit of the Swiss drug maker, Novartis,
sage to all stakeholders that Indian patent law cannot be is yet another case that will provide clarity on the applica-
exploited by any party and all such future litigations will tion of patent law in India, which is important to the eco-
involve a stringent fight over every minuscule aspect of nomic future of the country. In this case, which is presently
the issues involved.” Roche was granted Indian Patent No. before the Supreme Court of India, Novartis AG (Novartis)
IN ‘774 in February 2007, over the Erlotinib Hydrochloride challenges the order of the Intellectual Property Appellate
(EH) molecule which has demonstrated breakthrough ca- Board (IPAB), rejecting its patent application for Gleevec
pabilities as an Epidermal Growth Factor Receptor (EGFR)
inhibitor, which spiked survival benefit in non-small cell Number of patents granted from 2005-2006 to 2009-2010 for drugs in india
lung cancer (NSLC) patients. Cipla’s intention to launch a
generic version of Roche’s drug in January 2008, led Roche
to move Delhi High Court to seek injunction against Cipla
from marketing Erlocip. This case generated great interest
worldwide as it is believed to be the first case under India’s
new patent regime, where a generic company started sell-
ing a low cost version of a patented drug, well knowing the
consequences of a patent infringement.

According to the Indian Council of Medical Research, at
least 90,000 men and 79,000 women are diagnosed with
cancer of the lungs and bronchitis in India every year. The

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Top 10 major patent applicants from Pharmaceutical Industry After the 2005 amendment, Cancer Patients Aid Associa-
tion (CPAA) and several generic companies filed pre-grant
(beta crystalline form of imatinib mesylate), an anti-can- oppositions against Novartis’ patent application for ima-
cer drug used to treat chronic myeloid leukemia. Supreme tinib mesylate, claiming that Novartis’ alleged “invention”
Court’s ruling in this case will affect not only the patenting lacked novelty and that it was merely a “new form” of a
of this particular anti-cancer drug, but will also determine “known substance” that did not enhance the substance’s
the position in India on patenting of new forms of already efficacy and was thus not patentable under section 3(d).
known substances. Novartis has challenged the IPAB’s These arguments were based on the fact that Novartis had
interpretation of section 3(d) of India’s patent law and its already been granted a patent in 1993 in the United States
application to Novartis’ patent application for the beta- and other jurisdictions for the active molecule, imatinib
crystalline form of an already known substance, imatinib and that the present application only concerned a specific
mesylate. “Novartis does not have much to gain directly crystalline form of the salt form of that compound.
from this case, while the ruling may play a crucial role in
determining the limits of patentability and non-patentabil- “Novartis cannot be accused of evergreening”, says Ranjit
ity in India, with regards to the developed compounds”, Sahani, Chairman, Novartis, clearly dismissing the accusa-
says Prity Khastgir. tions. According to the company, imatinib mesylate is the
salt form of an older medicine, imatinib, and the new ver-
Section 3(d) of the Indian Patents Act, 1970 is the public sion represents a 30 per cent increase in the bioavailability
health safeguard in the Indian patent law, which amongst of the medicine. Affordability is a big issue. Novartis sells
others, disallows patenting of new forms of known sub- Glivec at Rs. 120,000 for 30 tablets a month in India. Ge-
stances, unless the new form exhibits a significant enhance- neric versions cost Rs. 8,000 to Rs 12,000. “Generic versions
ment in efficacy. It is one of the safeguards introduced by of Glivec are not the solution for the poor in India”, says
Parliament of India in 2005 to prevent evergreening. Ev- Sahani. “Respect for intellectual property will strengthen,
ergreening is the practice of pharmaceutical companies not weaken the Indian economy, helping India reach its as-
to obtain patents on frivolous or minor changes to known piration of becoming a pharmaceutical powerhouse”.
drugs and thereby establish or extend their monopoly over
a drug. Novartis argues that it invests more than USD 50 billion
each year in research and development (R&D) - the single
Case history most important source of investment in health research.
“Patents provide an incentive to the pharmaceutical indus-
In 1997, Novartis AG filed a patent application in the try to invest in the development of new medicines to treat
Chennai (Madras) Patent Controller’s office for the beta- diseases that are currently untreatable or incurable, and
crystalline form of imatinib mesylate, brand name Gleevec provide options when patients develop resistance to older
(Glivec) claiming that it invented the beta-crystalline form drugs”, says Sahani.
of imatinib mesylate, a salt of the free base, imatinib. The
case remained in cold box until 2005, after which India The Swiss drug company actively supports innovative ap-
amended its patent law to comply with its obligations under proaches to increase access to medicines, through public-
the TRIPS Agreement. private partnerships, tiered pricing arrangements and
shared contribution models in addition to donation pro-
grams. More than 95 per cent of all Glivec patients in India
receive their medicine free of charge through the Glivec In-
ternational Patient Assistance Program (GIPAP).

Global significance

Both these episodes (Cipla & Novartis) are extremely sig-
nificant and as they get argued thread-bare at the Court
and when final judgements come forth, the shape and
contours of the amended Patent Act will get more clearly
defined, landing a win-win for patients and public health.
“Because India is regarded as the pharmacy of developing
countries, the importance of these cases extend far beyond
India” says, Dr. Antani.

Source: Annual report of the o ce of the controller general of pat-
ents, designs, trade marks and geographical indication

52 LIFESCIENCE INDIA | October-November 2012

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Intellectual property rights:

The Indian scenario

The Indian Patent regime majority of patients (Compulsory li- its Patent Law to provide process and
censing case: Bayer vs Natco). product patent protection in all fields
is grappling with two of technology- including pharmaceu-
Patent act ticals and agrochemicals- to comply
issues, one addressing core with its obligations under the TRIPS
The last six years have seen an on-go- Agreement. The Indian Patent Act
patenting and the other ing legal battle between the govern- was amended and made compliant to
ment and drug manufacturers in the TRIPs consequently. A safety clause
relating to patented life- country. In the ‘Doha Declaration’ i.e. Section 3(d) was introduced to the
(2001), the World Trade Organization Indian Patent Act. The purpose of the
saving drugs. An appropriate (WTO) spelt out the agreement on clause was to safeguard public health
trade-related aspects of Intellectual and at the same time, curb ever-
response balancing Property rights (TRIPs) across coun- greening (making superficial changes
tries. This agreement allowed enough to known inventions). According to
international IP protection flexibility to member countries to section 3(d), technical creations are
protect the right of health of their not invention, unless they result in
obligations and domestic citizens. Until that year, India did not a significant increase in efficacy. It is
recognize pharmaceutical patents. As this Section 3(d) of the Indian Patent
needs would have a huge a WTO member however, it was ob- Act which is the bone of contention
ligated to later modify the patent re- in the case of Novartis versus Gov-
positive impact on the Life gime of the country to comply with the ernment of India. The history of this
TRIPs. The same year, India amended
Sciences sector.

-Shilpi Jha

Trade takes on a new meaning
in the current liberalized world,
with protection through patents
offering a larger control over the cre-
ative development to the person or
organization responsible for it. Such
a control assumes added significance
when viewed from the angle of its so-
cial and economic impact on countries
battling poverty and inequality.

The product patent, especially those
concerning pharmaceutical industry
continues to remain hanging, lacking
definition. The linkages of regulatory
mechanism and intellectual property
protection in the field of Life Scienc-
es are a cause for concern for policy
makers from the perspective of inno-
vation policy, public interest regula-
tions, trade and economics.

Currently, the Indian Patent regime is
struggling with two important issues.
One that addresses the core of pat-
enting in the country(Novartis versus
Government of India) and the other
relating to patent life-saving drugs
that are priced out of reach of a large

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case can be traced back to year 1997. Consequently, Novartis’ appeals were being the world’s biggest exporter of
Novartis AG filed a patent application transferred to the IPAB, a specialist cheap generic drugs, a win for No-
in the Chennai (Madras) Patent Con- tribunal on matters relating to intel- vartis would jeopardise the supply of
troller’s office for the beta-crystalline lectual property. cheap medicines to millions of people
of imatinib mesylate, brand name in the country and across the globe.
Glivec (Gleevec) on the grounds of in- The Novartis’ appeal challenging the
venting the beta crystalline salt form Patent Controller’s order was heard by In the event of Novartis losing the
(imatinib mesylate) of the free base, a specially constituted Bench of the case there will be clarity on decisions
imatinib. Novartis’ patent application IPAB, in 2008 where in IPAB over- regarding the kind of innovation that
was not taken up until 2005 as the turned the Patent Controller’s find- is patentable. There will also be clarity
Indian law did not provide for prod- ings on novelty and inventive step on the legal position on patenting new
uct patents till then. As per TRIPS and held that the beta-crystalline forms of already known or existing
Agreement, developing countries like form of imatinib mesylate was new drugs in the country. Besides, clarity
India were asked to introduce prod- and involved an inventive step. How- on interpretation and assessment of
uct patent protection to pharmaceuti- ever, the IPAB held that Novartis’ al- the efficacy of the medicine seeking a
cals and agrochemicals in early 2005. leged invention did not satisfy the test product patent will come about.
Since there was no patent protection of section 3(d) in as much as Novartis
available either, Novartis obtained did not provide data to show that the In short, an outcome, be it positive or
Exclusive Marketing Rights (EMR) for betacrystalline form of imatinib mesy- negative, will result in clarity on the
marketing Gleevec in India and hence late exhibited significantly enhanced interpretation of the Patent laws in
could prevent the generic manufac- therapeutic efficacy over imatinib me- India and the unique aspect of Indian
turers from manufacturing and sell- sylate. Hence IPAB rejected Novartis’ Patent act i.e. Section 3(d). The need of
ing generic versions of the medicine. appeal and refused to grant it a patent the hour is hence to define efficacy un-
for the beta-crystalline form of ima- ambiguously under section 3(d). This
After the 2005 amendment to the law, tinib mesylate. This order of IPAB was will result in informed decisions in the
generic companies filed pre-grant challenged before the Supreme Court future. The Supreme Court judgment
oppositions against Novartis’ patent in 2011. The major Issues of Conten- needs to be balanced keeping in mind
application for imatinib mesylate, al- tion involved what inventions were the socio-economic impact of grant-
leging that the invention lacked nov- patentable and what qualifications ing a patent to pharmaceuticals in a
elty as it was merely a new form for a were required for the granting of a country like India where more than
known substance with no enhance in Patent. Drawing attention to the ex- 30 per cent of the population lives be-
efficacy. In 2006, the Novartis’ patent penditure of $800 million on research low poverty line. After all, this is not a
application was rejected by the Patent to produce the subject drug, Novar- matter of Multinational Companies or
Controller in Chennai Patent Office tis claimed that patentability was generic drug manufacturers but about
agreeing with the contention of the required to encourage research and public health. India’s appropriate re-
generic companies that the mentioned development. Further, the company sponse to this challenge of balancing
subject application lacked novelty and staked its claim about the improved international IP protection obligations
was not patentable under section 3(d). efficacy demonstrated by the drug and domestic needs would have a huge
After the rejection of Patent Applica- Glivec, making it entitled to a patent. impact on the Life Sciences sector.
tion by Chennai Patent office, Novartis The case is currently subjudice before
AG and its Indian subsidiary, Novar- the Bench. Given that this is the first The writer is Deputy Director, Confederation
tis India, filed a series of writ petitions time the interpretation of section 3(d)
against the Government of India and of the Patent Act has come up before of Indian Industry.
Indian generic manufacturers (Natco, the Supreme Court, its outcome would
Cipla, Hetero and Ranbaxy), before have far reaching impact on the future
the Madras High Court challengeing of Indian Pharma.
decisions of the Patent Controller to
refuse to grant Novartis a patent for Case outcome
imatinib mesylate and the validity of
section 3(d) –which had served the In the event of Novartis winning the
ground for rejection of its Patent Ap- case the practice of Pharma Compa-
plication. In 2007, the hearing of the nies extending their patent terms by
appeals was referred to Intellectual making small and trivial changes to
Property Appellate Board (IPAB) by a existing molecules, thus preventing
notification of Government of India. the manufacture of generic drugs,
will gain legal sanction. With India

54 LIFESCIENCE INDIA | October-November 2012

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Shaping the biosimilars opportunity:

The global outlook for 2020

-Sourced from IMS Health Cost pressures key

After several years in the slow lane, important changes The changing outlook for biosimilars comes at a time when
are driving new momentum in the market for bio- the global pharmaceutical market is feeling the combined
similars, paving the way for their accelerated growth impact of two key events: a period of unprecedented patent
over the next decade and beyond. Although currently small expirations on many of the world’s largest pharmaceutical
and narrowly focused on a few disease areas and countries, brands, and a financial crisis that has required healthcare
the biosimilars opportunity is set to expand as patents ex- systems to make significant and sustained cost reductions.
pire on leading biologics, US legislation comes into effect,
and payers push for their wider adoption to manage bur- For payers in the advanced markets, limited economic growth
geoning costs. and pressures on healthcare make the patent cliff a true ge-
neric dividend, enabling much needed savings to be realized.
Analysis from IMS Health suggests that by 2015, sales of However, as potential savings from generics start to decline
biosimilars are expected to reach between US$1.9-2.6 bil- in these countries over the next 5-10 years while the imper-
lion, up from US$378 million in the first half of 2011. Po- ative to reduce expenditure continues to grow, payers face
tentially, this market could be the single fastest- growing an urgent need to find new ways of rationalizing resources.
biologics sector in the next five years – albeit from a small Biologics – among the most expensive pharmacotherapies
base – spurred by the convergence of major dynamics that available and now approaching their own swathe of patent
will see new biosimilars enter the US market by 2014, bring expirations – potentially represent the most lucrative source
additional molecules to Europe through 2015, and open up of savings on drug expenditure for Western nations after
oncology and autoimmune disease areas to biosimilars for 2015. Biosimilars may be the key that helps them to realize
the first time ever. this opportunity. Biosimilars also bring clear potential for
payers in the emerging pharmaceutical or “pharmerging”
markets, such as Brazil, India and China. Here, the need to

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broaden healthcare coverage to large populations increas- ing markets and any shortfall in quality standards that
ingly must be balanced against limited budgets and grow- prevents these countries from materializing as leading
ing demand for innovative drugs. Biosimilars offer one way exporters could impact overall potential.
of widening access and enabling better value to be obtained 3. Europe: Late-adopting major EU markets such as
from the money spent on healthcare. In some cases (such as Spain and Italy will need to follow Germany in terms of
South Korea, India and Brazil) they are seen as a key mac- biosimilars uptake to maximize prospects for growth;
roeconomic driver of growth, attracting foreign capital by it is possible that physician and payer resistance may
creating manufacturing and R&D centers of excellence. impede this, negatively impacting the 2020 outlook.
4. Technology: If the US is the key driver of upside poten-
Geographically, the market for biologics and biosimilars tial, the higher complexity of future biosimilar targets
falls into three distinct clusters: the US, the other advanced may be the barrier that hinders future growth. Techni-
economies (Europe, Japan and Canada) and the pharmerg- cal hurdles, particularly devices in the case of anti-TNFs,
ing markets. The US accounts for most of the global spend- will be a challenge for manufacturers and one that may
ing on biologics and will be a key driver of long-term bio- not be overcome by several companies at once. These
similars market potential. The advanced economies have issues could prevent biosimilars tapping into all ther-
the advantage of an established framework for biosimilars apy areas where biologics are off-patent, curtailing the
but the uptake has been slow; Europe is the most progres- number of successful launches across therapy areas.
sive. Some of the highest growth rates for biologics are cur- 5. Volume effect: There is potential for a significant
rently seen in the pharmerging markets, where biosimilars volume effect on biologics consumption, as observed
already exist (albeit through a looser regulatory pathway) with G-CSF in the UK and Sweden. This could drive
and where much of the immediate growth will be found. up biosimilars market growth considerably or equally
constrain it should uptake be insufficient to generate a
Within the three main geographic clusters, a number of spill-over incentive.
differentiating factors will impact the value generation op- 6. Competitive landscapes: The forecast assumes that
portunity for biosimilars, including ease of access in the major markets will drive positive financial returns and
short term, speed of uptake, clarity of regulation and, par- biosimilars growth, enabling a good degree of com-
ticularly, the role of public and private stakeholders. petition. Should financial barriers and poor uptake in
major markets yield a limited number of competitors,
Accordingly, most of the immediate value will be sourced growth prospects will be similarly reduced.
from the pharmerging markets, spurred by the anticipated
flow of new patients. However, in the long-run, the US will The biosimilars’ future
be the cornerstone of the global biosimilars market, power-
ing a sector worth between US$11 billion and US$ 25 billion To date, one of the main challenges for biosimilars has been
in 2020 representing a 4% and 10% share respectively of the the reluctance of payers, prescribers and patients to accept
total biologics market. The overall penetration of biosimilars these products in place of the original brands. Going for-
within the off-patent biological market is forecast to reach ward, the reaction of these stakeholders and the chosen
up to 50% by 2020, assuming a price discount in the range of strategies of aspiring players, and particularly innovators,
20-30% (or 40-50% with tender discounts included). will be key to their speed of uptake:

Underlying this forecast are six core drivers with the poten-
tial to spur or curb future growth of the biosimilars mar-
ket: the US uptake, the spread of biosimilars in pharmerg-
ing markets, the continued pattern of evolution in Europe,
technology and the second wave of biosimilars, volume ef-
fect and the competitive landscape.
1. US uptake: The core upside driver of biosimilars value

in 2020 is uptake in the US long-term (2014-15), un-
locking market potential and economies of scale. Any
limitations on this, for example due to regulations fa-
voring innovator companies, will drive down the likeli-
hood of significant growth.
2. Pharmerging markets: Growth is also dependent on
the pharmerging countries becoming a key biosimilars
player in terms of both manufacturing and market size.
The more moderate spread of biosimilars in develop-

56 LIFESCIENCE INDIA | October-November 2012



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• Payers: As yet, biosimilars have not been a key priority gylated, long-acting formulations, and have sought to
for payers and there has been little, if any, top-down establish these newer versions as the standard of care.
pressure urging a move to extensive biosimilar prescrib- This has met with some success in certain areas – most
ing. Limited price discounts, sophisticated products and notably with Amgen’s launch of Aranesp and Neulasta,
lack of familiarity with their use has perhaps made the second generation versions of Epogen and Neupogen
decision less clear cut than for small molecule gener- respectively. More sustainably, originators have estab-
ics. Going forward, however, this is likely to change as lished extremely strong relationships with prescribers,
biosimilars move into the higher cost areas of oncol- KOLs and patients, based on services, clinical develop-
ogy and autoimmune diseases and efforts to rational- ment and investment, which biosimilars may struggle
ize healthcare intensify. Emphasis will be placed on the to replicate. Patent disputes, especially in the US, where
strongest assurances of clinical safety and efficacy. the legislation requires disclosure of patent information
by the biosimilar manufacturer, may also delay or pre-
• Patients: Increasingly vocal in their treatment decisions, vent the entry of some biosimilars.
patients are also becoming more focused on broader
and affordable access to treatment. However, it is likely Challenging arena
that they will be heavily influenced by physician guid-
ance on administration of biosimilars and they may not For new entrants, biosimilars pose very different challenges
even be aware whether they are being treated with a to those presented by small molecule generics, with more
biosimilar or an originator product. demanding requirements in terms of clinical development,
market access, manufacturing and sales and marketing ca-
• Physicians: Lack of experience with biosimilars and the pabilities:
newness of the regulatory pathway have led to a natu- • High development costs: Developing a biosimilar is
ral conservatism in prescribing approach among many
physicians. The learning curve has yet to be built and not a simple process but one that requires significant
overcoming safety and efficacy concerns will be para- investment, technical capability and clinical trial ex-
mount to their acceptance of biosimilars. Usage will vary pertise. Average cost estimates range from US$100-250
by therapy area but it is likely to be contained to small million if plant development is included (or US$20-100
groups of new patients initially, with close monitoring of million for non-plant cost). Whilst lower than the costs
outcomes before considering more widespread use. of developing a small molecule NCE, they are never-
theless orders of magnitude higher than the costs as-
• Aspiring players: With significant capital invested in sociated with developing traditional generics, which are
biosimilars, the entry of branded players bringing R&D typically around US$1-4 million.
capabilities, and biosimilars addressing multiple areas • Fledgling regulatory framework: In most markets
of the strategic agenda, would-be entrants are clearly apart from Europe, the regulatory framework for bio-
key to the sector’s success going forward. similars is generally still very new compared to the
well-established approval process for NCEs and small-
• Originators: The lifecycle management strategies of molecule generics; in some cases it is non-existent,
the originator companies have an important role to play making global investments risky
in driving volume expansion, with the power to limit • Manufacturing issues: Barriers to developing a bio-
uptake opportunities in advanced economies whilst similars manufacturing capability are not prohibitive,
growing penetration in pharmerging markets. but the development of biosimilars involves sophis-
To date, many originators have chosen to develop bio- ticated technologies and processes, raising the risk of
betters or functionally enhanced biologics, such as pe- the investment.In the near term, entrants face limited
benefits of scale, relative to incumbents, and in specific
areas such as insulins, strict requirements for compat-
ibility with existing devices will apply.
• Branded mentality: Winning the trust of stakeholders
will call for many of the skills, resources and branded
mentality of a conventional innovative pharmaceutical
company – potentially involving changes to commercial
models. Initiatives to allay safety concerns among phy-
sicians and patients will be particularly important, sup-
ported by sales teams with deeper medical and techni-
cal knowledge. This will mean significant investment
in sales and marketing – initially at least – using either
internal commercial capabilities or by sourcing these
from branded companies.

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Investment in pricing and market access will also be in- mature and pharmerging markets. Nevertheless, there are
creasingly important: post-marketing surveillance is al- major barriers in place which mean that it may be challeng-
ready mandatory in Europe and the US is likely to follow ing to be successful. The biosimilars sector is also at very
The higher break-even requirements and technology barri- different stages in each of the major regions and will likely
ers associated with biosimilars are likely to make the com- take a different course. Ultimately, from the heterogeneous
petitive arena less crowded than generics. group of biosimilars entrants and would-be players, the
number of winners may be small.
Compelling returns, wide appeal Companies looking to take advantage of the biosimilars
opportunity will need to be clear of their strategic relevance
Despite the inherent risk, the expected productivity of in- within the organization, in terms of portfolio fit, financial
vesting in biosimilars could match or exceed benchmark suitability and synergies within the value chain, bearing
returns from R&D. In fact, simulating the potential internal in mind that this may be an established or pharmerging
rate of return (IRR) of a biosimilar investment compared to markets play. A full understanding of the financial upsides
an industry benchmark shows that it could actually yield a and risks of the investment will be critical, based on real-
higher IRR than developing a brand new biologic. istic scenarios of the size of the potential, the therapy reas
where it will be found, and whether collaboration and alli-
Furthermore, biosimilars can fit within the strategic agen-
da of various company profiles – as demonstrated by the ances are required to access the necessary skills. An effec-
eclectic mix of innovator manufacturers, generics houses tive market access strategy will be vital for successful entry:
and players from other industries that are already enter- the value proposition is complex and will need to address
ing the sector. They offer a source of long-term financial the full range of stakeholders – including payers, physi-
returns, an opportunity to address diminishing pipeline cians and patients whose opinion will be critical. Robust,
productivity and a basis for building an R&D platform for up-to-date intelligence will also be key: competitors will be
the future. Importantly, too, they provide access to the fast- diverse and their quantity unknown. Above all, companies
growing pharmerging markets where critical new patient will need commitment: the prospects are good and grow-
segments are easier to penetrate. The enormous potential ing but biosimilars will likely be a long-term game.
of the pharmerging markets is a key upside driver and for
many companies a principal reason for investing in biosim- Source: White Paper on Biosimilars: IMS Health
ilars despite the high financial barriers short-term.

Tapping the potential

Unlocking the potential of biosimilars will require a focused
strategy along the whole value chain, from optimizing the
clinical development program through developing the
most suitable strategy for commercialization. Balancing the
trade-off between in-house versus strategic alliances will
be essential for achieving cost efficiencies and speeding up
time to market, with further tailoring by geography to cope
with a heterogeneous landscape. Entry into pharmerging
markets, for example, will be strongly governed by partner-
ships with local players.

The opportunity afforded by biosimilars can be consid-
ered from two different standpoints: either as a means of
protecting current value or as a source of new value gen-
eration. For companies focused on value protection, evalu-
ating and mitigating risk will be key with a view to opti-
mizing resource allocation post-LOE; those looking to join
the biosimilars journey will need to thoroughly assess their
strategic fit, the building blocks for successful entry and the
optimal go-to-market model design. (Use Figure 9 from the
original PDF document)

To date, limited experience with biosimilars captures only a
small portion of their anticipated future potential, as pow-
erful economic pressures increase their appeal to payers in

LIFESCIENCE INDIA | October-November 2012 59

LSI The world is faced with a situation
FEATURE of fast depleting source of fossil
fuel, forcing countries to urgently
60 LIFESCIENCE INDIA | October-November 2012 look for sustainable supplements.
Biofuels have emerged as a possible
alternative that not only reduces
global dependence on oil but also
serves as a green option lowering
carbon footprints. However, a lot
needs to be done to make biofuels
viable on a greater scale without
posing a threat to food security.

-Nandhini Sundar

The global fossil fuel scenario is anything
but rosy with its finite source fast deplet-
ing, calling for an urgent replacement with
non-conventional sources. The global population
growth and fast-growing energy consumption in
under developed countries is expected to push
up global energy demand by 50 per cent by 2035.
Global fossil fuel usage, that includes coal, oil and
natural gas, has been consistently rising over the
last two and a half decades.

In the energy matrix, oil continues to remain the
world’s leading fuel at one-third of global energy
consumption, followed by coal. According to the
BP Statistical Review of World Energy 2012, world
proved oil reserves at the end of 2011 reached
1652.6 billion barrels, barely sufficient to meet
54.2 years of global production; a pointer that fos-
sil fuels will run out in fifty years from now and
perhaps earlier if consumption increases. Clearly
there is an urgent need to re-look at our energy
consumption patterns and also to find alternate
sources that are not only sustainable but serve as
greener options, reducing carbon footprint.

It is in this perspective ‘Biofuels’ have emerged
as a major source to supplement fossil fuels, with
many developed countries already producing sig-
nificant amounts and mandatorily blending the
same with their fossil fuel. Ethanol accounts for
nearly 70 per cent of biofuel production in the
world and the balance 30 per cent comes from
biodiesel. Biofuels, chiefly comprising of ethanol
made from corn or sugarcane or biodiesel made
from vegetable oil, are fast emerging as an al-
ternate eco-friendly solution to the conventional

LSI
FEATURE

fossil fuel source of energy. Plenty of options are being ex- blended with petrol. However, given the cyclical nature of
plored for using agricultural produce as a source of fuel for sugarcane production, ethanol production is erratic, with
generating energy as well as addressing the fuel require- 2.15 billion litres produced in 2008 of which 280 million
ments of the automotive industry. While fossil fuels cannot litres were blended with petrol. This came down to 1.07 bil-
be completely replaced with biofuels, it proposes to offer an lion litres in 2009, allowing only 100 million litres of it to
active supplement that can reduce the world’s dependence be blended.
on oil. Essentially, the generation of biofuel involves extrac-
tion of ethanol from feed stocks such as molasses, sugar- Vegetable oils like rapeseed, mustard, soybean or oil palm
cane, corn and tree-borne inedible oils like Jatropha and are not used for production of biodiesel. Instead tree-borne
pongamia for the production of biodiesel. An advantage of non-edible oilseeds like Jatropha and pongamia are used.
the tree-borne inedible oilseeds is the scope for them being Besides avoiding conflict of food vs fuel, Jatropha is an ani-
cultivated in barren waste lands that are unfit for cultiva- mal deterrent and also assists in the build-up of soil carbon.
tion of food crops. Requiring minimal care, water as well as soil fertility, its
high oil content and low gestation period serves as an ideal
Indian scenario source for generating biodiesel. The cake obtained after oil
extraction can be used as organic manure for preparation of
The fourth largest consumer of petroleum, after the US, herbal insecticides and biogas.
China and Japan, India’s domestic production of crude oil
from fossil fuels has remained stagnant around 30 per cent Ethanol from alternative sources
of consumption, with the rest being sourced through im-
ports. The production of crude oil in the country amount- Plenty of alternatives have been explored to source bio-
ed to 38.9 million tonnes for the year 2010-11 with total fuel. Sweet sorghum is one of them, given its advantages
petroleum consumption currently standing at 148 million of rapid growth, wider availability, high biomass produc-
tonnes. Not surprisingly, there is pressure on the balance ing availability with sugar-rich stalks and suitability for
of payments with the escalating import bill touching $135 seed production and mechanised cropping. Besides, cost of
billion in 2011-12, registering a 22 per cent increase over production of sweet sorghum based ethanol is considerably
the previous year. lower than molasses based ethanol. Tropical sugarbeet is
another potential source for ethanol production. Field tri-
As a green option, the Government of India has actively als conducted by Tamil Nadu Agricultural University have
looked at the biofuel alternative to reduce fossil fuel con- indicated that tropical sugarbeet can be cultivated exten-
sumption, but unlike the developed countries, only non- sively in the country. The average recovery rate of ethanol
food feedstock is promoted for biofuel production. Besides, is 80 to 90 litres per tonne of sugarbeet, indicating a far
care is taken to prevent fertile lands from coming under higher rate of recovery as compared to molasses or sweet
biofuel production. Biofuel planting happens only on sorghum and a much lower cost of production of Rs 12 to 14
wastelands, fallow lands and forest areas. After a few initial per litre. However, the commercial feasibility and viability
initiatives, the National Biofuel Policy, formulated by the of such feedstock is yet to be ascertained and requires more
Ministry of Renewable Energy, was released in December research and policy measures to promote the same.
2009. India is the largest producer of ethanol from sugar-
cane molasses with the molasses coming entirely from sug- National Biofuel Policy
ar production. The recovery rate of ethanol from molasses
stands at 22 to 25 per cent, with a total production of 1.43 The National Biofuel Mission (NBM) was launched in the
billion litres in 2010 of which about 50 million litres were year 2003, under the aegis of the Planning Commission,
Government of India. It laid special focus on the expan-

LIFESCIENCE INDIA | October-November 2012 61

LSI
FEATURE

sion of area under biofuel feedstock crops like Jatropha Jatropha plant with fruits
and pongamia by laying an ambitious target of bringing
11.2 to 13.4 million hectares of land under its cultivation sations. These state level policies are however designed to
by year 2011-12. Bringing the forest and waste lands under ensure there is no conflict with the National biofuel policy.
their cultivation was the other aspect promoted. Further, The State of Rajasthan, for example, promotes biofuel crop
the blending of biofuels with petrol and high speed diesel planting program in wastelands. The state also views this
on a commercial scale was envisaged under NBM through as a soil conservation technique besides greening waste-
the Ethanol Blended Petrol Program (EBPP) and Biodiesel lands and increasing employment opportunities for mar-
Blending Program (BDBP). ginal households. For instance, 21 lakh hectares of waste-
lands were to be brought under Jatropha curcas.
In year 2003, 5 per cent ethanol blending in petrol was
made mandatory in 9 states and 5 union territories to in- Likewise, the state of Chhattisgarh, which has favourable
crease the use of biofuels. This was further expanded to climatic conditions for cultivation of Jatropha and ponga-
cover 20 states and 8 union territories in 2006 but the re- mia, has several subsidy and tax exemption programs in
sponse was lukewarm due to the low availability of ethanol place to promote the biofuel sector in the state. In the state
at the prevailing support price. Even after the government of Uttarakhand, Van Panchayats are actively involved in
revised the purchase price close to Rs 27 per litre in April biofuel promotion and the state has a mandate for cover-
2010, ethanol blending still remained below targeted levels. ing an area of 2 lakh hectares under Jatropha cultivation by
In sharp contrast, Brazil, another country heavily depen- year 2012. The state of Odisha is aiming to use 30 per cent
dent on imported oil, is already blending 20 per cent etha- of the state’s wastelands with an expected generation of 10
nol with petrol and diesel. The target now is to raise this million person-days of work through biofuel production,
to 25 per cent in the coming years if sugarcane production with the biofuel production pegged at 1000 KL per annum.
supports it. The policy also looks at potential inter-linkages between
biofuel program and various development programs.
To emphasise more on biofuel, the National Biofuel Policy
formulated by the Ministry of Renewable Energy was re- Karnataka, being a sugarcane surplus state, while empha-
leased in December 2009. The policy foresees biofuels as a sising on ethanol production from molasses, also permits
potential rural employment generation with environmen- direct conversion of sugarcane into ethanol after fixing a
tal and economic benefits arising on a large scale from the ceiling for sugar production. The State Biofuel Policy also
growth of non-edible oil seeds like Jatropha and ponga- encourages public-private partnership models through
mia and the reclamation of waste and barren lands for their long term lease of waste lands for the cultivation of biofuel
cultivation. The policy also proposes to set up a National feedstock. A Biofuel Park was set up in the district of Has-
Biofuels Development Board (NBDB) to promote the use of san in 2006 and currently has a capacity to produce over
biofuels in petrol and diesel engines within a specified time 250 litres of biodiesel a day.
frame through appropriate policy measures. To enable the
same, the indicative target of 5 per cent blending by 2012
and 20 per cent by 2017 was set.

To enable free movement of biofuels between states, the
policy also proposes it to be brought under the ambit of
‘Declared Goods’ besides giving tax exemption to the same.
A National Biofuel Fund was proposed to provide financial
incentives in the form of subsidies and grants to new and
second generation feed stocks, new technologies and con-
version processes. To attract FDI, 100 per cent foreign eq-
uity is permitted into biofuel technologies and projects on
condition that the biofuel generated is purely for domestic
consumption.

State specific policies

While the National Biofuel Policy chalks out the broad out-
line for the country for promoting biofuels, individual states
have come up with individual biofuel policies which are
implemented through state level agencies like Panchayat
Raj, forest departments, universities and research organi-

62 LIFESCIENCE INDIA | October-November 2012

LSI
FEATURE

In Tamil Nadu, the state, besides promoting contract farm- require the availability of high yielding, drought tolerant
ing for Jatropha cultivation, also set a target of promoting Jatropha seeds. To meet the target of 5 per cent blending
100,000 ha of Jatropha plantation over a period of five years in the current year, an estimated 3.21 million tons of biod-
under its State Biofuel Policy released in 2007-08. iesel would be required. With Jatropha being the major
feedstock for generating biodiesel, at an average yield of 2.5
Price hike for sustainability tons per hectare and 30 per cent biodiesel recovery rate, it
would require 18.6 million hectares to be brought under its
To make cultivation of Jatropa remunerative in year 2011, cultivation to meet the target of 20 per cent blending by
Confederation of Indian Industries (CII), recommended 2017 and 4.1 million hectares to meet the target of 5 per
that the price of biodiesel sourced from Jatropha should cent blending.
be hiked to Rs 36 per litre as compared to the prevailing
Rs 26.5 per litre. According to the study, even if the blend- Slow adoption
ing initiative of 2 per cent of Jatropha based bio-diesel is
achieved by 2012, the country would save around Rs 3000 Though India’s oil bill is shooting up every year, generation
crores besides generating revenue of Rs 5500 crores in the of biofuel is far from what is needed. Biofuel production in
rural economy and creating an investment opportunity of the country is still at its nascent stage with about 95 mil-
Rs 1700 crores on an annual basis. Besides, a reduction of 3 lion litres produced from Jatropha and pongamia oil. While
million metric tonnes of Greenhouse Gas emissions would multiple reasons similar to what the rest of the countries
be effected as a result on an annual basis. across the globe are facing act as the deterrent, some of
them merit mention. A chief factor is the restricted avail-
Currently, the total ethanol supply is expected to be just ability of land and water affecting the cultivation of biofuel
sufficient to meet the 2 per cent blending target while the crops. Indian farmer’s lack of confidence in biofuels as well
production of biodiesel from Jatropha is commercially in- as their awareness of biofuel crops being restricted to one
significant. The target of 5 per cent blending of ethanol or two again hinders biofuel industry. The long gestation
has been partially successful only in the years of surplus typically associated with Jatropha and pongamia acts as a
sugar production. Increasing the biodiesel production will deterrent for them to take up their cultivation.

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LSI
FEATURE

While a significant number of facilities exist for process- work in the field of biofuel as petrol in the US is blended
ing bioethanol, very few exist for processing biodiesel. The with ethanol made from corn. China extracts ethanol from
sector also lacks research towards development of a wide wheat, cassava, sweet sorghum along with corn while Eu-
variety of crops to suit the varied environmental conditions ropean Union, another major ethanol producer, extracts it
in the country as well as to acquire advanced technologies from cereals like wheat, corn, barely and sugarbeet.
for oil extraction for biodiesel. In terms of policy support,
there is absence of binding policies and proper planning. Diversion of food crops
Physical infrastructure to support a biofuel industry of that
size is yet to be implemented and currently, the actual pro- But there is a growing concern against diverting agricultural
duction of biofuel is less than 10 per cent of the estimated land to produce fuels for running cars. Given the increased
potential. emphasis laid on greener sources of energy, many biofuel
producing countries like the US, EU, Canada, China, di-
The government has encouraged private sector players in verted food crops for production of bioenergy. For instance,
producing biofuels as companies like Reliance Life Sciences, in 2008, 95 million tonnes of corn, which formed roughly
Bharat Petroleum, Bharat Renewable Energy Ltd have come 12 per cent of global corn production, was diverted for bio-
forward. Reliance, for example, has started work in produc- fuel production. Interestingly, 80 per cent of it was used by
ing biodiesel (from Jatropha and other non-food oil seed the US. Under the US law, 40 per cent of corn harvest must
crops), bioethanol (from cellulosic biomass) and biobutanol be used for biofuel; a quota which the UN warns could con-
(from cellulosic biomass). Reliance Life Sciences claims that tribute to world food crisis.
it has successfully developed high-yielding composite va-
rieties of Jatropha, developed improved strains of marine In the EU, 15,514 million litres of biofuels is required for
algae, developed a plant tissue culture protocol for Jatropha 2012 to meet the 5.75 per cent mandatory blending target.
and commissioned a 6,500 tonnes per year pilot plant for Its biofuel production 2010 was around 10,000 million litres,
biodiesel production. up by 3 times since 2005. The use of cereals for biofuel pro-
duction is expected to increase at 10 per cent annually till
Global scenario 2017 while the growth of cereal production is expected to
remain at 1.4 per cent. This clearly indicates the ensuing
India, of course, has a lot to learn from major global achieve- pressure on food grains for human consumption.
ments. Brazil has realised the highest per hectare yield in
ethanol production at 5476 litres/hectare of sugarcane pro- Biofuel from waste
duce, clocking 74.5 litres/tonne of sugarcane. About 55 per
cent of the sugarcane production is directly used to con- Production of biofuel from waste is a less controversial op-
vert into ethanol in contrast to countries like India, where tion being considered in many countries. Interesting ele-
ethanol is produced from molasses, which is a by-product ments that have come about are agricultural waste com-
of sugarcane. The US is the other country doing serious prising of the part of crop which is not eaten, like the husk,
stalks, wood chippings, chicken feather meal which con-
Source: BP Statistical Review of World Energy June 2012
sists of processed chicken feathers,
blood and innards, and a very un-
likely item, garbage in landfills.

According to a study conducted by
the National University of Singa-
pore in 2009, about 82.93 billion
litres of cellulosic ethanol could be
generated from available landfills of
the world, with the resulting biofuel
cutting down on carbon emissions.
As for agricultural waste, it is esti-
mated that half of Europe’s gasoline
demands can be met by merely us-
ing 20 per cent of agricultural and
forest residue available there for
generating biofuel. However, many
of these possibilities need to pass
through commercial feasibilities
and state approvals to become po-
tential sources of biofuel.

64 LIFESCIENCE INDIA | October-November 2012

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EVENT

Collaborate

e ectively for

greater utilisation

Delegates at the CII-ASEAN Conclave at New Delhi of resources*

-Jiggyasa Srivastava H.E. Ms.Tan Poh Hong, Chief Executive Officer, Agri-
Food & Veterinary Authority of Singapore
Department of Agricultural Research and Education H.E. Mr. Theera Wongsamut, Minister of Agriculture
(DARE)/Indian Council of Agricultural Research and Cooperatives, Thailand
(ICAR) and Confederation of Indian Industry (CII) H.E. Mr. Diep Kinh Tan, Vice Minister of Agriculture
jointly organized the second ASEAN-India Ministerial and Rural Development, Viet Nam
Meeting on Agriculture & Forestry on 17th October, 2012, H.E. Mr. Lim Hong Hin, Deputy Secretary-General of
followed by a Symposium on 18th October, 2012 on Indo- ASEAN for ASEAN Economic Community
ASEAN Export potential of Agriculture Products at NASC
Complex, Pusa, New Delhi. Key discussions:

The ASEAN-India Ministerial Meeting was Co-Chaired by Addressing the issue of food security, the Ministers reaf-
Mr. Sharad Pawar, Minister of Agriculture and Food Pro- firmed their support to enhance cooperation on food se-
cessing Industries of India and H.E Mr. Vilayvanh Phom- curity through various activities, among others, including
khe, Minister of Agriculture and Forestry of Lao PDR. S research and development, capacity building, and technical
Ayyappan, Secretary, Department of Agricultural Research cooperation as guided by the ASEAN-India Leaders during
and Education (DARE), and Director General, Indian Coun- their 9th ASEAN-India Summit, held on 19th November
cil of Agricultural Research (ICAR), Rajesh Ranjan, Direc- 2011 in Bali, Indonesia.
tor, DARE and senior officials of DARE and ICAR were also
present on the occasion. The Ministers noted that the long term partnership between
ASEAN and India has resulted in a significant increase in
The Ministers, Vice-Ministers, SOM leaders and senior of- their total trade from US$ 55.3 billion in 2010 to US$ 68.4
ficials of the ASEAN nations and India participated in the billion in 2011, making India the sixth largest trading part-
meet with a view to collaborate more effectively for greater ners of ASEAN. The Ministers also noted that the trade in
utilisation of resources in agriculture, industries and trade. agriculture commodities account for 16.7 per cent of the to-
tal trade in 2011, amounting to U$$ 11.4 billion. The Min-
The ASEAN members who attended the meeting were: isters further noted that the foreign direct investment from
H.E. Pehin Dato Yahya, Minister of Industry and Pri- India to ASEAN has increased by 28.6 per cent from US$
mary Resources, Brunei Darussalam 0.8 billion in 2009 to US$ 2.8 billion in 2010.
H.E. Mr. Kith Seng, Under Secretary of State, Ministry
of Agriculture, Forestry and Fisheries, Cambodia Expressing their concern over the insufficient involvement
H.E. Dr. Rusman Heriawan, Vice Minister of Agricul- of young farmers’ in the agricultural sector, the Ministers
ture, Indonesia agreed on the importance of promoting innovation and en-
H.E. Dato’ Mohd Hashim bin Abdullah, Secretary trepreneurship among young farmers to achieve more sus-
General, Ministry of Agriculture and Agro-Based In- tainable agricultural development in the region.
dustry, Malaysia
H.E Mr. Ba Hla Aye, Charge d’Affairs, Minister Coun- The Ministers welcomed the development of the ASEAN-
sellor, Embassy of the Republic of the Union of Myan- India Roadmap on Climate Change Adaptation and Miti-
mar to India gation in Agricultural Sector to address the impact of cli-
H.E Ms. MA Agnes Cervantes, Consul General of the mate change.
Embassy of Philippines to India

LIFESCIENCE INDIA | October-November 2012 65

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The Ministers agreed that the ASEAN-India Agri Expo pro- Indian Council of Agricultural Research welcomed the dig-
vides a venue for farmers and private sector to keep abreast nitaries and hoped that deliberations in the symposium
with the achievements and new innovations in agricultural will help identify mutual areas of cooperation and related
sector. The Ministers agreed that the ASEAN-India Agri challenges.
Expo will provide opportunities to create new as well as
strengthen existing business networks to explore possible While elaborating upon agricultural education, research
investment collaboration in the agricultural sector. and extension strength of ICAR, he suggested to utilize this
valuable resource for the betterment of our agricultural sec-
The Ministers expressed concern on the price volatility of tor and bring greater happiness for our farmers, consumers
food commodities and their impact on developing coun- and industry. “Several ASEAN member states enjoy excel-
tries and resolved to strengthen cooperation by widening lent agro-climatic conditions suitable for production of the
food production base and exchange of expertise between commodities that India imports in large quantity. Similarly,
ASEAN and India to enhance their resilience in food secu- India can be an important source for many of the commod-
rity planning. ities imported by ASEAN member states. I am, therefore,
of the view that member countries can be benefited if we
The dignitaries launched the India-ASEAN News on Ag- explore the complementarities and align our agricultural
riculture and Forestry, a bi-annual newsletter published by productions and trade policies to encourage greater bilat-
ICAR. The newsletter will act as a window for activities, eral trade in agro commodities”, said Shri Harish Rawat.
achievements, agricultural research information and policy
issues related to the member-countries. Pawar, in his mes- The Symposium was also attended by Shri Abhijit Sen,
sage, hoped that this newsletter will provide a strong inter- Member, Planning Commission and Guest of Honour of
active platform for mutual benefit of the ASEAN member the occasion who traced back the economic cooperation in
countries and India. the ASEAN region and expressed satisfaction over growth
of trade between India and ASEAN countries. “I hope that
The Ministers welcomed the significant progress in the im- the leaders, policy planners and traders gathered here will
plementation of the on-going ASEAN-India Medium-Term deliberate on the bottle-necks, challenges and issues which
Plan of Action (2011-2015) which forms part of the key de- are hampering trade. A road map must be devised and de-
liverables for the ASEAN-India Commemorative Summit signed to accelerate the agri-trade between India and ASE-
to be held on 20-21 December 2012, in New Delhi, India, to AN countries”, he added.
celebrate ASEAN-India dialogue relations.
While delivering a special address H.E Dr. Rusman Heri-
The Third ASEAN India Ministerial Meeting shall take awan, Vice Minister of Agriculture, Indonesia in his inau-
place in Malaysia in September/October 2013. gural address appreciated India and its economic growth.
“ASEAN is looking for strong economic cooperation with
The Association of South-east Asian Nations (ASEAN) is India for mutual benefits for the prosperity of the region”,
a group of ten nations–Brunei Darussalam, Cambodia, In- he said.
donesia, Lao PDR, Malaysia, Myanmar, Philippines, Sin-
gapore, Thailand and Vietnam, established on 8th August Mr. Xaypladeth Choulamany, Director General, Depart-
1967 in Bangkok, Thailand with an objective to accelerate ment of Planning and Cooperation, Laos PDR in his special
the economic growth, social progress and cultural devel- address emphasized the growing need of mutual coopera-
opment in the region, to collaborate more effectively for tion among ASEAN nations and India in trade, agriculture
greater utilisation of resources in agriculture, industries and other sectors.
and trade, and to promote active collaboration and mu-
tual assistance in the economic, social cultural, technical, Mr. Ashwin Shroff, Chairman, CII National Sub-Com-
scientific and administrative fields. mittee on Agri-Biotechnology & Chairman and Manag-
ing Director, Excel Industries Ltd gave a brief deliberation
Symposium on Indo-ASEAN Export potential of Agricul- on ‘Export Potential of Agriculture Produce’ in which he
ture Products elaborated challenges and suggested way outs.
On 18th October, the symposium on “Indo-ASEAN Export
potential of Agriculture Products- Growth Potential and The symposium was organized into four different sessions
Way Forward’ was inaugurated by Shri Harish Rawat, Min- with experts on the panel. The First Session called up dis-
ister of State for Agriculture, Food Processing Industries & cussion on “Export potential of Indian Agricultural prod-
Parliamentary Affairs, Government of India. ucts to ASEAN”, Chaired by Dr. Anup Kalra, CEO, Ayurvet
Limited. The other eminent speakers of the session were
Dr. S. Ayyappan, Secretary, DARE and Director General, Mr. V.K. Kaul, Deputy General Manager, Agricultural &

66 LIFESCIENCE INDIA | October-November 2012

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EVENT

Processed Food Products Export Development Authority; Session IV was meant for a Panel Discussion on “Vision
Mr. Sonal Tyagi, Chief Manager-International Business, on Agriculture Import-Export promotion among ASEAN-
Escorts Agri Machinery and Mr. C.S. Shukla, Head Busi- India”, chaired by Dr. S. Mauriya, Assistant Director Gen-
ness Development Seeds, DCM Shriram Consolidated Ltd. eral (IP and TM), Indian Council of Agricultural Research.
and Professor Ramesh Chand, The eminent panellists of the session were Mr. Nguyen Thi
Thanh Thuy, Deputy Director General, Department of Sci-
The second session discussed “Import Export Potential ence, Technology and the Environment, MARD, Vietnam;
of Agricultural Products among ASEAN-India”. This ses- Dr. Suresh Pal, Head Division of Economics, IARI, New
sion was Chaired by Prof Tahlim Sudaryanto, adviser to Delhi ; Mr. Ashwin Shroff, Chairman, CII National Sub-
the Minister of Agriculture, Indonesia. Sam Nuov, SOM- Committee on Agri-Biotechnology & Chairman and Man-
AMAF leader, Deputy Director General, Ministry of Agri- aging Director, Excel Industries Ltd ; Dr. A.K. Srivastava,
culture, Forestry, and Fisheries, Cambodia. Other Speakers Director, National Dairy Research Institute.
of the sessions were Mr. Tran Van Cong, SOM leader –Di-
rector-Global Integration and Foreign Investment Division, Dr. D. Sengupta, Senior Adviser, Confederation of Indian
Vietnam; Dr. J.S. Samra, CEO, National Rainfed Area Au- Industry (CII) proposed the vote of thanks.
thority and Dr. Rameshwar Singh, Project Director, Indian
Council of Agricultural Research. ASEAN-India Agriculture Expo was another attraction of
the Meeting. The research and development in the field of
Session III of the symposium discussed “the Regulatory Is- agriculture was displayed by the member countries.
sue in Agricultural Products Import and Export”, and was
Chaired by Dr. Arvind Kumar, Deputy Director General, *Above report is on the proceedings of Second ASEAN-
ICAR. The main speakers in this session were Dr. K.K. Tri- India Ministerial Meeting on Agriculture and Sympo-
pathi, Scientist G, Department of Biotechnolgy; Dr. Kailash sium on Indo-ASEAN Export potential of Agriculture
Chander Bansal, Director, National Bureau of Plant Genetic Products.
Resources and Ms. TAN POH HONG, Chief Executive Of-
ficer, Agri-Food & Veterinary Authority of Singapore.

Interview

Promote innovation
through young farmers

We need to involve young The Co-operation between India- partner with ASEAN with trade in
farmers in the agriculture ASEAN on agriculture development agriculture commodities accounting
sector to stress on promot- started last year in Jakarta during the for 16.7 per cent of the U$$ 11.4 bil-
ing innovation and entrepreneurship first ministerial meeting. Under this lion total trade in 2011. Foreign direct
says Dr. Rusman Heriawan, Vice Min- cooperation we have short term and investment from India to ASEAN has
ister of Agriculture, Indonesia (ASE- mid-term plan of action. The short increased by 28.6 per cent from US$
AN member country) in a chat with term is already passed and the mid- 0.8 billion in 2009 to US$ 2.8 billion
Jiggyasa Srivastava on the joint efforts term will extend from 2011 to 2015. in 2010. ASEAN-India relationship
between India and ASEAN nations to India is highly developed in terms of will provide new opportunities and
promote agricultural development. agriculture with immense experience strengthen existing business net-
to offer in plant breeding, agricultural works to explore possible investment
Q. How would you define relation- technology, developed seeds, har- collaboration in the agriculture sector.
ship between India and ASEAN vesting/post harvesting technology India has agreed to provide training
nations in the field of agriculture? etc. India is the 6th largest trading programs with two such training pro-

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COVER STORY

Dr. Rusman Heriawan ship amongst them. The Farmers
Exchange Program will create
grams in Bhopal already in place. India and ASEAN have greater awareness among young
agreed upon Farmers Exchange Program to create greater and innovative farmers. An in-
awareness among young and innovative farmers. The first tegrated step to develop collab-
Exchange Visit will be conducted in Malaysia in conjunc- orative projects covering aspects
tion with the 2012 ASEAN Farmers Week and the Malay- related to production enhance-
sian Agriculture, Horticulture and Agro-tourism (MAHA) ment programs, maintenance
International in November 2012 and the second Exchange and management of stocks, ad-
Visit in India in December 2012. equate availability of grains, ac-
cess of food to vulnerable popu-
Q. What are the common challenges faced by India and lation and inducing transparency
ASEAN nations in agriculture? What solutions would in markets, shall further address
you offer? challenges of this sector.
Both are striving towards increased agricultural produc-
tion and productivity for food security while addressing Q. How would you define the
increased frequency of drought, floods and heavy rainfall. trade relationship between In-
Development of relevant cropping technologies, risk man- dia and Indonesia?
agement practices and sharing of knowledge will help both India and Indonesia enjoy a very
to enhance production even during adverse climate. warm and “Strategic partner-
ship” in the region which has
There is need to involve young farmers in the agriculture grown tremendously the last few
sector and promotion of innovation and entrepreneur- years.

India is a major importer of our
Palm oil with a turnover of $5
billion. Our trade has outgrown
the set targets well before sched-
ule displaying the strong bond
the two countries. In 2005, a tar-
get of achieving $10 billion trade
turnover by 2010 against the pre-
vailing $4 billion was set and this
was achieved in 2008.

Q. How do you see this graph progressing and what
should be done to give a new dimension to this rela-
tionship?
As the global economy is still in the recovery stage and
western countries are still grappling with various econom-
ic issues, this provides great opportunity for India and In-
donesia to capitalise on the situation. Both nations should
have a more diversified basket of goods and services to take
the economic partnership to a new level.

The biggest challenge in agriculture trade in Indonesia is
how to get value chain from a product. Indonesia is the
biggest exporter of Palm oil.

We need to look at the downstream industry and think of
developing derivative products from Palm oil as well to be
more competitive in the world. Same is the case with our
Rubber industry. India has great experience in the down-
stream industry and an exchange of technology between
the two shall strengthen the relationship further.

68 LIFESCIENCE INDIA | October-November 2012

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NEWS

DBT-BIRAC Innovator Award

Department of Biotechnology (DBT), One of the award winners with Dr. M K Bhan
Ministry of Science and Technology,
Government of India and Biotech- Specific Issues in Priority Technology Guided Robotic Positioning System
nology Industry Research Assistance Areas such as Healthcare, Biomedical (ROBIO EX) and Automated Device
Council (BIRAC) organised the DBT- Devices & Diagnostics, Agriculture, for Planning, Execution and Confir-
BIRAC Innovators Meet on 15 – 16 Industrial Products & Green Technol- mation of Targeted Tumor Ablation
October, 2012 at Manesar, Gurgaon. ogy. There was also a very stimulating Therapy (MAXIO)
This provided an effective platform discussion in the Performance Mea-
to highlight the innovation research surement session moderated by World Industrial Processes and Green Tech-
done through public private partner- Bank experts. DBT-BIRAC Innovation nology Sector : Pelican Biotech and
ship (PPP) & for assessing the success Awards were conferred on the most Chemical Labs Pvt. Ltd., Alppuzha,
achieved in developing innovative outstanding innovators in Biotechnol- Kerala for their contribution in Novel
technologies for affordable product or ogy in following sectors: Methods for Isolation of Biochemicals
technology development through the and Value Added Products from Crus-
PPP model. Agriculture Sector : Bioseed Research tacean Exoskeleton. Navya Biologicals
India Pvt. Ltd., Hyderabad and In- Pvt. Ltd., Hubli, Karnataka for their
This meeting was inaugurated by ternational Centre for Genetic Engi- contribution in Paltform Technologies
Dr. M. K. Bhan, Secretary, DBT, and neering & Biotechnology, New Delhi for Production of Complex Proteins,
Prof. G. Padmanaban, delivered the for their contribution in Rice Hybrids Peptides and MABs.
Keynote address. It was attended by with Improved Characteristics
nearly 200 Scientists from Industry, The Awards were presented by Dr. M.
Academia including Universities, Re- Healthcare Sector : Strand Life Sci- K. Bhan, Secretary, DBT. In the Inau-
search Institutes, Senior Experts from ences Pvt. Ltd., Bangalore for their gural Address, Dr. Bhan announced
World Bank, Policy Makers and En- contribution in Hepatotoxicity Pre- the launch of the Social Innovation
trepreneurs and the meet facilitated diction Platform (Heptox). Biomedi- Scheme, which will operate from
knowledge sharing, networking and cal Devices, Implants & Diagnostics April, 2013. Posters were also dis-
strengthening of collaborations be- Sector : Perfint Healthcare Pvt. Ltd., played by nearly 20 Industries on their
tween researchers and Biotech Com- Chennai for their contribution in CT project achievements.
munity at large, for innovation and
promoting research efforts of Indian
industries. The main objective of this
meet was to critically analyse the on-
going DBT-BIRAC schemes & initia-
tives that support industry-academia
driven nationally relevant products/
processes development and commer-
cialization.

The two day intensive interaction be-
tween industry-academician–policy
makers provided key recommenda-
tions on critical issues imperative for
the growth of biotech sector. Plenary
sessions were conducted on Science
to Business - Building a Biotech En-
terprise, Discovery Led Innovation
Research – Challenges and Oppor-
tunities, Innovators Forum - a Two
Minute picture by the Innovators,
Breakaway Sessions for discussion on

LIFESCIENCE INDIA | October-November 2012 69

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Stop GM crop trials: SC panel recommends

In a severe blow to the future of ge- considered for testing be evaluated by tor, Advanta India Ltd, one of India’s
netically modified (GM) food crops in rodent-feeding trials. largest agrochemical companies with
the country, a high-level committee interests in seeds and biotechnology.
appointed by the Supreme Court has The recommendations are significant
recommended stopping all ongoing because the committee was peopled The committee’s recommendations
open field trials on such crops for 10 by scientists, said Kavitha Kuruganti also come on the back of an August
years until a new set of conditions is of the Coalition for a GM-Free India. parliamentary panel report criticizing
enforced. the introduction of Bt cotton as well as
“The committee had scientists from tests on GM food crops.
Two years ago Ministry of Environ- the Centre for Cellular and Molecular
ment had ordered trials of Bt brinjal. Biology and the National Institute of The panel’s study on Cultivation of
These fresh recommendations are Nutrition, and the decision has fol- Genetically Modified Food Crops—
more significant as they constitute lowed an extensive review process,” Prospects and Effects was among the
a key input to the Supreme Court of said Kuruganti, “But as of today, field most extensive studies conducted by
India, which has been hearing a pub- trials will be illegal only if the Su- a parliamentary standing committee.
lic interest litigation (PIL) filed by a preme Court says so.” The panel received 467 memorandums
clutch of independent scientists as and 14,862 documents, and reviewed
well as activist organizations. She added that further deliberations evidence given by 50 organizations
on the case are expected on 29 Oc- during its 27 sittings on the subject.
Key recommendations by the com- tober. India’s seed industry, several
mittee include a reassessment of the constituents of which have bet on the While the development was discour-
biosafety data that is generated by future of GM crops, described the rec- aging, there will be further debate,
field trials; ensuring there is no con- ommendations as “adverse”. said another seed industry executive.
flict of interest (that is, those tasked
with evaluating the biosafety of GM “I haven’t seen this report and know “It’s bad news, but there will be more
crops are themselves not stakehold- no details. But if this is the recom- hearings,” said K.K. Narayanan,
ers in promoting such crops); a ban on mendation, that could have adverse managing director, Metahelix Life
outsourcing or subcontracting field implications for the industry,” said Sciences Ltd, which has interests in
trials; and ensuring that crops being V. Ram Kaundinya, managing direc- both GM cotton as well as GM rice.
“I don’t think it’s curtains for the in-
dustry yet.”

A Supreme Court bench headed by
former chief justice S.H. Kapadia had
in May sought a report within three
months from an expert committee
on whether there should be a blanket
ban on field trials for GM crops, and if
not, had asked it to detail a procedure
to establish the safety of such crops.
The orders came on a PIL filed by
non-governmental organization Gene
Campaign and activist Aruna Ro-
drigues, who had sought a complete
moratorium on field trials for GM
crops. Scientists in the country, how-
ever, have jointly opposed the recom-
mendation of the SC panel.

Source: Mint

70 LIFESCIENCE INDIA | October-November 2012

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NEWS

Union government announces Rs 1,300 crore for free medicine scheme

Union health minister Ghulam Nabi centres, 5,000 community health cen- esthetic agents, lipid lowering agents,
Azad has cleared Rs 1,300 crore un- tres and 640 district hospitals. steroids and anti platelet drugs) to
der the National Rural Health Mis- all the states to use it as reference to
sion (NRHM) for states to support Planning Commission says 39 mil- prepare their EDL. A Planning Com-
their purchase of medicines. The fund lion Indians are pushed to poverty mission panel had recently said drug
will not only help buy general drugs because of ill health every year. A prices have shot up by 40% between
for government-run hospitals but ministry official said it is being made 1996 and 2006. It said that during the
also those needed under the Janani- mandatory for all doctors in the public same period the price of controlled
Shishu Suraksha Karyakram (JSSK). sector to prescribe generic drugs and drugs rose by 0.02%, while those in
Under the JSSK, all pregnant women salt names and not brands. The Cabi- EDL increased by 15%. The price of
delivering in public health institutions net has approved the setting up of a drugs that were neither under price
are entitled to free and cashless deliv- Central Procurement Agency (CPA) control, nor under EDL grew by 137%.
ery, free C-section, exemption from for bulk procurement of drugs. "Only A study by the Public Health Founda-
user charges, free medicines, blood, a handful states will be able to roll tion of India recently found that while
consumables and diagnostics and free out free medicines by this year end," India's per capita OOP expenditure
diet for three days in case of normal a ministry official said. The ministry for healthcare costs has gone up from
delivery and seven days in case of C- has sent the National List of Essential Rs 41.83 in 2005 to Rs 68.63 in 2010,
section. Medicines, 2011, (348 drugs which the per capita spending on drugs in-
includes anti-AIDS, analgesics, anti- creased from 29.77% to 46.86% dur-
The minister has also asked the states ulcers, anti psychotic, sedatives, an- ing the same period.
to prepare a policy articulation docu-
ment, an essential drugs list and stan- Type 2 diabetes: Study to track causes and mechanism
dard treatment protocols and intro-
duce a procurement system and supply TheCouncilofScientific and Industrial Research (CSIR)
chain management. "States already has embarked on a India-wide quest to determine the
have a budget to purchase drugs but it causes and mechanism of type 2 diabetes in Indians. In-
isn't enough. The latest allocation is to dia has the highest number of diabetics in the world—
support the state budget for 2012-13," 50.8 million—and type 2 is the more common and com-
said a ministry official. plicated affecting almost nine out of every 10 diabetics.
The Indian Diabetes Consortium, a Rs 100 crore initia-
Officials said that states will have to tive that involves researchers and physicians from cen-
procure drugs through an open ten- tres such as the Institute of Genomics and Integrative Bi-
der. Companies applying for the ten- ology, a CSIR laboratory, and hospitals such as the All India Institute of Medical
ders will have to have good manufac- Sciences will compare the genomes of nearly 22,000 Indians for variations in
turing practices compliance certificate, specific locations of their DNA. Genome-wide association studies harness com-
a no-conviction certificate and should puters to see how different the genomes of diabetics look from those who don’t
have a specified annual turnover. The have the condition. Currently, around 40 genes are suspected to play a role in
drugs will also have to carry a not-for- type 2 diabetes, with CSIR team already having zeroed in a handful of genes
sale label printed on the packaging. that may be linked to childhood obesity.

The ministry says upto 75% of pri- People with type 2 diabetes cannot use the insulin they produce effectively, but
vate out-of-pocket (OOP) health ex- can often manage their condition through exercise and diet, although many
penditure is on purchasing drugs of require medication, including insulin, to properly control blood glucose levels.
which 76% is spent on purchasing It is estimated that 60% or more of instance of type 2 diabetes can be prevent-
OPD drugs. The free medicines for all ed. Both type 1 and type 2 diabetes represent a serious health threat. Diabetes
the programmes are estimated to cost claims four million lives every year and is a leading cause of blindness, kidney
Rs 28,560 crore during the 12th five failure, heart attack, stroke and amputation, according to a report by the Bel-
year plan. At present, the public sec- gium-based International Diabetes Federation (IDF). The rarer type 1 diabetes
tor provides healthcare to 22% of the (which accounts for just around one-tenth of the total cases of diabetes) arises
country's population and it is likely to from insulin deficiency, usually because of a disorder in the pancreas where this
swell to 52% by 2017 once medicines enzyme is produced.
are provided for free from 1.6 lakh
sub-centres, 23,000 primary health Source: Mint

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Major global pharma companies Digital PCR: Improving Nucleic Acid Quanti cation

join hands for drug discovery Researchers at Harvard Medical School are studying the differences in human
genomes to identify the genes underlying biological processes and human disease.
Ten leading biopharmaceutical One of the researchers, Professor Steve McCarroll, is analyzing the copy number
companies have formed a non- variations (CNV) of genome segments from tens to hundreds of thousands of base
profit organization to accelerate pairs long. This requires the ability to measure the precise copy number of these
the development of new medicines. segments in thousands of individuals.
Abbott, AstraZeneca, Boehringer
Ingelheim, Bristol-Myers Squibb, Using technologies such as real-time PCR (qPCR) and comparative genomic
Eli Lilly, GlaxoSmithKline, John- hybridization arrays, the McCarroll lab could measure simple deletions and
son & Johnson, Pfizer, Genentech duplications-changes in copy number from two to one or zero, or from two to
and Sanofi launched TransCelerate three or four. But what they lacked was the ability to precisely and reproducibly
BioPharma, the largest ever ini- measure copy numbers greater than four.
tiative of its kind, to identify and
solve common drug development Bio-Rad Laboratory’s QX100 Droplet Digital PCR (ddPCR) system provides an
challenges. It also aims at improv- absolute measure of target DNA and RNA molecules. It can be used to discriminate
ing the quality of clinical studies small-fold differences in copy number, enabling researchers to measure 1, 2, 3, 4,
and bringing new medicines to 5, 6, or more copies.
patients faster. Through participa-
tion in TransCelerate, each of the Whereas qPCR quantifies nucleic acids by comparing the number of amplification
ten founding companies will com- cycles and amount of PCR end-product to those of a reference sample, droplet
bine financial and other resourc- digital PCR enables researchers to directly quantify nucleic acids. In other
es, including personnel, to solve words, ddPCR does not re-quire the use of a standard curve. Although qPCR is
industry-wide challenges in a col- a viable detection strategy when mutant and wild-type sequences are mixed, its
laborative environment. Together, effecti-veness declines when the mutated sequence is relatively rare, such as in
member companies have agreed to myleoplastic syndromes (<20–25%).
specific outcome-oriented objec-
tives and established guidelines for Droplet Digital PCR separates samples into 20,000 droplets, and reactions are
sharing meaningful information carried out individually in each. This reduces background interference for more
and expertise to advance collabo- reliable and sensitive measurement of low concentrations of nucleic acid that may
ration. Members of TransCelerate not have been detectable using qPCR.
have identified clinical study exe-
cution as the initiative's initial area Droplet Digital PCR technology takes advantage of simple microfluidic circuits
of focus. Five projects have been and surfactant chemistries to divide a 20 µL mixture of sample and reagents into
selected by the group for funding. 20,000 droplets with target and background DNA randomly distributed among
them. These droplets support PCR amplification of single template molecules
Wockhardt launches generic of using assay chemistries and workflows similar to those for qPCR applications (i.e.,
TaqMan).
anti-ulcer drug Prevacid
After PCR amplification occurs, a reader determines which droplets contain a target
Pharma major Wockhardt received and which do not. Software calculates the concentration of target DNA as copies
final approval from the US FDA for per microliter from the fraction of positive reactions using Poisson statistics.
marketing 15mg and 30mg delayed
release capsules of Lansoprazole, In digital PCR, having more partitions provides greater precision and resolution
which is used in treatment of peptic for detecting small concentration differences. Sample partitioning to levels
ulcers. Lansoprazole is the generic above 10,000 allows for extremely accurate Poisson correlations and substantial
name for the brand Prevacid, mar- enrichment effects when screening for rare events. The QX100 is the only digital
keted in the US by Takeda. Wock- PCR system that generates uniform droplets to partition a target sample. Others
hardt will be manufacturing the use microfluidic chips, which are challenging to scale to higher partition numbers
Lansoprazole API in its facility at per sample while maintaining low costs.
Ankleshwar, India, and the delayed
release capsules of Lansoprazole at The main application areas of this technology are – Gene Expression Analysis,
its facility in Aurangabad, India. Copy Number Variation Determination and Rare Event Detection.
The technology for the API and the
capsules were developed in-house.

72 LIFESCIENCE INDIA | October-November 2012



October – November 2012 (Pages 64+4) DELENG18266/29/1/2012-TC

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